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CompletedNCT03284528Updated Sep 21, 2017

Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"

An observational study in Asphyxia Neonatorum, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Open to participants aged 1 Day to 4 Days. Per ClinicalTrials.gov, last updated 2017-09-21.

Sponsored by University Children's Hospital, Zurich · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
1 Day to 4 Days
Sex
All
01

Study summary

The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24 months of age.

02

Conditions studied

03

Who can participate

Ages eligible
1 Day to 4 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All newborn infants with a gestational Age >35 weeks, fulfilling the inclusion criteria of perinatal asphyxia and hypoxic-ischaemic encephalopathy, born in Switzerland and treated in the University Hospital of Zurich with hypothermia therapy after birth

Eligibility criteria

Inclusion Criteria:all newborn infants with APGAR \<5 at 10minutes, pH\<7.0, lactate >12mmol/L, base excess >16, resuscitation >10min after birth, gestational age >35 weeks and an encephalopathy -

Exclusion Criteria:

-

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Otherhypothermia therapy

    newborn infants with hypoxic-ischaemic encephalopathy are cooled for 72 hours with a target temperature of 33-34°C (whole body cooling).

05

What researchers measure

Primary outcomes

  1. neurodevelopmental outcome at 18-24 month of Age

    The investigators will analyse if there is a correlation of placenta histology and neurodevelopmental outcome

    Time frame: 7 years

06

Study locations

1 site
  • University Children's hospital Zurich
    Zurich, 8044, Switzerland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03284528
Lead sponsor
University Children's Hospital, Zurich
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Jan 1, 2011
Primary completion
Jan 1, 2017
Completion
Jan 1, 2017
Last update
Sep 21, 2017

Study contacts

Barbara Brotschi
principal investigator · University Childrens's hospital of Zurich

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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